Zai Lab (ZLAB) said Monday that the US Food and Drug Administration has granted fast-track designation to ZL-1310, the company's potential antibody-drug conjugate for the treatment of extensive-stage small cell lung cancer.
The drug, currently being evaluated in a phase 1 clinical trial already received an FDA orphan drug designation for small cell lung cancer, the company said.
Fast-track designation will mean more frequent engagements with the FDA and eligibility for accelerated approval and priority review, the company said.
Shares of the company were up more than 2% in recent premarket activity.